India’s drug regulator may scrap need to renew licences and approvals

The government is planning a major overhaul of the country's drug policy, with moves that include scrapping the need to renew manufacturing licences and easing regulations to allow medical and drug research here.ET Bureau | October 07, 2016, 13:14 IST

NEW DELHI: India's central drug regulator is considering changes to the Drug and Cosmetics Rules like extending the validity of various licences and approvals in a move to improve ease of doing business for the industry. The announcement comes on the heels of a PMO-backed message by the Niti Aayog to examine and remove all regulatory hurdles faced by the industry.

The government is planning a major overhaul of the country's drug policy, with moves that include scrapping the need to renew manufacturing licences and easing regulations to allow medical and drug research here.

The central drug regulator is in the process of revisiting the 1945 Rules to see if the validity of various licences and approvals can be made perpetual, according to a notice dated October 6. This would remove the need for drug and cosmetic makers to periodically renew licences for the manufacture, sale and distribution of their products.

The extension is also being considered for the approval of laboratories for test analysis of drugs, according to the notice.

This is provided the licences and approvals are not cancelled or suspended by the licencing authority, according to the notification.

"However, there should be assessment of compliance with the conditions of licences/approvals at least once in 10 years," added Drugs Controller General of India (DCGI) G.N. Singh in the notice to all state drug regulators and pharma industry associations.

The Central Drugs Standard Control Organisation (CDSCO) is also considering updating the rules to ensure that the Good Manufacturing Practices (GMP) are at par with the World Health Organisation GMP guidelines, according to the notice.

"Keeping in view the Government of India's policy to bring ease in doing business for making the "Make in India" concept a reality, CDSCO is in the process of revisiting the following regulatory provisions…to further improve the quality of services provided by the drug regulatory authorities of the States and Centre," Singh stated.

CDSCO has sought comments, suggestions and inputs on the proposed moves by October 21 in order to take a considered view in the matter.

The body has so far taken various steps to streamline import clearances and registration of drugs, medical devices and cosmetics, among other aspects. It has also initiated risk-based inspections of drug manufacturing facilities and has engaged in training state and central regulatory officials to improve the quality of the service they provide, according to the notice.

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